Manufacture and biosafety testing of a gamma retroviral vector

General Information Short Title: " Manufacture and biosafety testing of a gamma retroviral vector " Document Type: Notice of Intent to Sole Source Solicitation Number: N02RC62697-6 Posted Date: 09/08/2016 Response Date: 09/12/2016 2:00 PM EST Classification Code: A - Research and Development NAICS Code: 611710 - Educational Support Services Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES Description: The National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch plans to procure on a sole-source basis Gamma Retroviral Supernatant production and biosafety testing services. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 611710 and the business size standard is $15.0M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance shall be twelve (12) months from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. Project Objective: The Surgery branch is a combined laboratory and clinical research unit devoted to the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer. Efforts run the gamut from basic studies of cancer immunology to the conduct of clinical immunotherapy trials for patients with metastatic cancer. While waiting for the new Surgery Branch Vector Production Facility (SBVPF) to come online, the branch needs the immediate manufacture and biosafety testing of a gamma retroviral vector encoding a TCR targeting the KRAS G12D hotspot mutation for NCI clinical trials Requirements: Government Requirements: NCI/CCR/ Surgery Branch will supply to the contractor gamma retroviral vector producer cell line clones and the nucleotide sequence of the gamma retroviral vector for gamma retroviral vector production. Contractor Requirements: The Contractor requirements are as follows: - The Surgery Branch/NCI will require the production and biosafety testing of a single gamma retroviral. - The contractor shall be responsible for development of Standard Operating Procedures (SOP's), Quality Assurance (QA) practices, qualification of production components, preparation of batch records, and the issuance of final reports containing the certificates of analysis for the stated product or assay. - All manufacturing and biosafety testing will comply with current Points to Consider and 21CFR regulatory guidelines as stipulated by the Food and Drug Administration (FDA). - The contractor will also be responsible for providing monthly progress reports on the status of individual projects or assays. - All manufacturing and testing will be in compliance with current requirements for cGMP Phase I/II FDA Submissions. Requirements for the Production and Biosafety Testing of Gamma Retroviral Vector Supernatants: Following certification of the MCB, initial gamma retroviral vector supernatant production will be initiated. Conditions for production will be based on the pilot production run conditions approved by the Surgery Branch/NCI or predetermined production conditions agreed upon by the Surgery Branch prior to production. An aliquot of the MCB will be expanded sufficiently to collect a large amount of supernatant from the gamma retroviral vector producer cells. The minimum volume for satisfaction of this production agreement is 10 liters; however, an attempt should be made to produce a minimum of 9 liters of vector product. The product will be harvested, filtered, frozen and maintained at < -70o C in aliquots (100 grams/unit). If the titer of the production is within 20% of that obtained when the MCB was approved and the Surgery Branch/NCI elects to not accept the production, a preparation charge may be assessed. If the production fails one or more of the certification tests, except the sterility or mycoplasma, the Surgery Branch/NCI will be assessed the costs of all production and testing initiated at the time of discontinuation of the study. If the sterility or mycoplasma test fails, contractor will complete a new production at no additional charge. Aliquots of supernatant from the production run will be supplied to the Surgery Branch/NCI for titer determination. The contractor will be responsible to conduct certification assays based on current FDA guidelines. Certification of the supernatant will include the tests listed below and will not be initiated until the titer of the production has been approved by the Surgery Branch/NCI. Subject to review of current FDA requirements, certification will include: - Sterility, Aerobic and anaerobic culture for bacterial and fungal contamination. Fully meets or exceeds 21 CFR 610.12 - Mycoplasma, Including broth, agar, and cell culture and meets the recommended procedure for mycoplasma testing according to the Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, Attachment #2 (1993). - In-Vitro Adventitious Virus Assay: Including amplification on three cell lines and hemadsoprtion with three species of red blood cells. - GAL-V RCR, 108 post-production cells and 5% of the supernatant from the final harvest will be tested for GAL-V RCR by extended S+L- assay using the 293 and PG-4 cell amplification and detection system. - Endotoxin: An aliquot of the final harvest will be evaluated for endotoxin by the LAL gel clot method. The value will be considered acceptable if the result is less than or equal to 0.3 EU/ml. - Vector insert stability. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 2:00PM EDT, on Sept. 12, 2016. All responses and questions must be in writing and emailed to Jolomi Omatete, Contracting Officer via electronic mail at contact@example.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02RC62697-6 on all correspondence.